mRNA-1273 SARS-CoV-2 vaccine: Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
BNT162b2: A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
ChAdOx1-S [recombinant]: A colourless to slightly brown, clear to slightly opaque solution containing 5 x 1010 viral particles (not less than 2.5 x 108 infectious units).
0, 28 day schedule: Second injection administered 28 days post first injection
0, 112 day schedule: Second injection administered 112 days post first injection
Covifenz: COVIFENZ is an emulsion for intramuscular injection. The 3.75 mcg antigen component of COVIFENZ is a suspension, which must be mixed 1:1 with the 0.25 mL AS03 adjuvant emulsion component prior to administration
Study summary
The main goals of this study are to assess the immune response and safety of two different vaccines for first, second, third and fourth doses as well as for differing intervals between the first and second dose of two-dose vaccines.
Eligibility
Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
Accepted
Inclusion Criteria:
1. Participant is willing and able to give written informed consent to participate in the study
2. Age 18 years of age or older in good health or with mild or moderate stable co-morbidities at the time of enrolment
3. Able and willing to complete all the scheduled study procedures during the whole study follow-up period
4. If female of child-bearing potential and heterosexually active, has practiced adequate contraception for 30 days prior to injection, has a negative pregnancy test on the day of injection, and has agreed to continue adequate contraception until 3 months after the final dose of study vaccine (Please refer to the definition section for a description of child-bearing potential and adequate contraception)
5. MOSAIC-1 Vaccine-exposed subgroups: have received or are booked to receive the first dose of an authorized COVID-19 vaccine in the 55 days prior to Visit 1 (documentation of receipt required)
6. MOSAIC -1 Vaccine naïve subgroups: have not received an authorized COVID-19 vaccine at any time
7. MOSAIC-2 participants have received two doses of COVID-19 vaccines authorized in Canada ≥6 months prior to study vaccine administration (documentation of receipt required)
8. MOSAIC-3 participants have received three doses of COVID-19 vaccines authorized in Canada ≥3 months prior to study vaccine administration (documentation of receipt required)
Exclusion Criteria:
1. Inability or unwillingness of participant or legally acceptable representative to give written informed consent
2. Any confirmed or suspected immunosuppressive or immunodeficient state; asplenia, or immunosuppressant medication within the past 6 months except short term oral steroids (≤14 days duration) or topical steroids
3. Current diagnosis or treatment for cancer (except basal cell carcinoma of the skin)
4. Administration of immunoglobulins and/or any blood products within 3 months preceding the first dose of study vaccine and for one month after the last dose of study vaccine
5. Allergy to any study vaccine or any active substance in a study vaccine
6. Bleeding disorder or history of significant bleeding following IM injections or venipuncture
7. Continuous use of anticoagulants
8. A history of anaphylaxis to a previous vaccine
9. Pregnancy or intent to become pregnant during the study or within 3 months of the last dose of study vaccine
10. MOSAIC-1: History of laboratory-confirmed COVID-19 disease prior to enrolment by participant report
11. Administration of a live virus vaccine within 4 weeks prior to study vaccine receipt.
Primary outcome measure(s)
Antibody response to SARS-CoV-2 S protein after 2 doses — Day 56 The co-primary outcome for the non-inferiority comparison of 0, 28-day schedules with heterologous second dose is the immune response to SARS-CoV-2 at day 56 (28 days after the second dose of vaccine) based on anti-spike antibody titers.
Antibody response to SARS-CoV-2 S protein after 2 doses — Day 140 The co-primary outcome for the non-inferiority comparison of schedules in which the timing of the second dose of vaccine is different (0, 28 days v 0, 112 days) is the immune response to SARS-CoV-2 at day 140 (28 days after the last dose in the 0, 112 day schedule) based on anti-spike antibody titers.
Antibody response to SARS-CoV-2 S protein after 3 doses — Day 28 To determine if a vaccination schedule with a heterologous third dose of a COVID-19 vaccine induces a non-inferior serum immune response to SARS-CoV-2, compared to a third dose/booster with a homologous vaccine.
Antibody response to SARS-CoV-2 S protein after 4 doses — Day 28 To determine if a vaccination schedule with a heterologous fourth dose of a COVID-19 vaccine induces a non-inferior serum immune response to SARS-CoV-2, compared to a third dose/booster with a homologous vaccine.
Trial sites (8)
Facility
City
Region
Status
Royal Inland Hospital
Kamloops
British Columbia
Penticton Regional Hospital
Penticton
British Columbia
BC Children's Hospital Research Institute
Vancouver
British Columbia
Children's Hospital Research Institute of Manitoba
Winnipeg
Manitoba
Canadian Center for Vaccinology
Halifax
Nova Scotia
Ottawa Hospital Research Institute, University of Ottawa
Ottawa
Ontario
McGill University Health Centre Vaccine Study Centre
Montreal
Quebec
CHU de Québec, Université Laval
Québec
Quebec
More Canadian Immunization Research Network trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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